FDA Radiology AI Devices

Velmeni for Dentists (V4D) is a computer-assisted detection software that helps dentists identify dental caries, restorations, fixed prostheses, and implants in various types of dental radiographs such as bitewing, periapical, and panoramic images. It uses machine learning algorithms to analyze radiographs and highlight areas of interest, providing additional information to aid clinical decisions without replacing dentist judgment.

MI View&GO by Siemens Medical Solutions USA, Inc. is medical diagnostic software designed to assist healthcare professionals in viewing and analyzing medical images from multiple modalities including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids in radiotherapy treatment planning by providing users with tools for image manipulation, quantification, and comparison at or near the scanner console, enhancing workflow efficiency and diagnostic accuracy.

The syngo.via MI Workflows, including Scenium and syngo MBF, is a multi-modality software platform developed to assist healthcare professionals in viewing, manipulating, quantifying, and analyzing medical images from various imaging modalities, including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids physicians in radiotherapy treatment planning by harmonizing PET data and providing standardized analysis tools such as brain amyloid quantification.

Imbio PHA (4.0.0) is a medical image processing software designed to measure the maximal diameters of the heart's right and left ventricles, the main pulmonary artery, and the ascending aorta from CT pulmonary angiography scans. It uses artificial intelligence to identify and measure these structures, providing annotated images and summary reports to assist clinicians in evaluating cardiovascular health.

The uMI Panorama is a combined PET/CT diagnostic imaging system designed to assist healthcare professionals in detecting and evaluating diseases like cancer, heart, and neurological disorders. It fuses PET metabolic functional imaging and CT anatomical imaging with advanced AI algorithms to improve image quality, reduce artifacts, and enhance diagnostic confidence. It supports PET/CT and single modality CT imaging, including low dose CT lung cancer screening, providing comprehensive information for patient management.

The Overjet Charting Assist is a software system that helps dental professionals analyze 2D dental X-rays by detecting natural dental structures like tooth anatomy and numbering, as well as restorative dental work such as crowns and implants. It supports clinicians by automating dental chart creation from images, aiding in more precise and efficient dental assessments.

NeuroQuant is an automated software device designed to help clinicians by providing automatic labeling, visualization, and volumetric measurement of brain structures and lesions from MRI scans. It enhances clinical workflow by delivering segmented images and morphometric reports that can be reviewed and compared to normative data, aiding in diagnosis and monitoring of neurological conditions.

AiMIFY is a software that enhances contrast in brain MRI images after they have been taken, making lesions and other features easier for radiologists to see. It uses machine learning to improve image quality without requiring direct interaction with MRI machines, helping clinicians better identify abnormalities in the brain.

The Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system produced by Canon Medical Systems Corporation. It provides high-quality cross-sectional images of anatomical structures in the head or body, including advanced imaging techniques such as non-contrast enhanced MRA and diffusion imaging. The AiCE Reconstruction Processing Unit uses AI to enhance and speed up the image reconstruction process, helping clinicians obtain clear and detailed MR images for diagnosis.

HealthCCSng is a software tool that uses artificial intelligence to automatically detect and measure calcified plaques in the coronary arteries from routine non-gated, non-contrast CT scans. It provides an exact calcium score and categorizes the amount of calcium present, with results integrated into the radiologist's workflow to assist in assessing risk for coronary artery disease.